According to studies reported by the Centers for Disease Control and Prevention (CDC): the National Health and Nutrition Examination Survey (NHANES) and the National Health Interview Survey (NHIS), more than two-thirds (68.8 percent) of adults over 20 years of age are considered to be overweight or obese. Additionally, more than one-third (35.7 percent) of adults are considered to be obese and more than 1 in 20 (6.3 percent) have extreme obesity.
Additionally, the National Institute of Health reports that overweight and obesity are risk factors for type 2 diabetes, heart disease, high blood pressure, and other health problems such as nonalcoholic fatty liver disease (excess fat and inflammation in the liver of people who drink little or no alcohol), osteoarthritis (a health problem causing pain, swelling, and stiffness in one or more joints), some types of cancer: breast, colon, endometrial (related to the uterine lining), and kidney as well as stroke.
Not exclusively a United States problem, worldwide obesity ranges are also increasing dramatically. The World Health organization reports that Worldwide obesity has more than doubled since 1980 and in 2014, more than 1.9 billion adults, 18 years and older, were overweight. Of these over 600 million were obese.
There is no single cause of all overweight and obesity and although the physiology and psychology of obesity are complex, the medical consensus is that the key contributing factor is an over intake of calories combined with reduced energy expenditures. There is no single approach that can help prevent or treat overweight and obesity. Treatment may include a mix of behavioral treatment, diet, exercise, and sometimes weight-loss drugs. In some cases of extreme obesity, weight-loss surgery may be an option.
Bariatrics is the field of medicine encompassing the study of overweight, its causes, prevention and treatment. Bariatric surgery is a treatment for morbid obesity that involves alteration of a patient's digestive tract to encourage weight loss and to help maintain normal body weight. Known bariatric surgery procedures include jejuno-ileal bypass, jejuno-colic shunt, biliopancreatic diversion, gastric bypass, Roux-en-Y gastric bypass, gastroplasty, gastric banding, vertical banded gastroplasty, and silastic ring gastroplasty.
There have been many attempts in the past to surgically modify patients' anatomies to attack the over-consumption problem by reducing the desire to eat. Stomach stapling, or gastroplasties, to reduce the volumetric size of the stomach, therein achieving faster satiety, were performed in the 1980's and early 1990's. Although patients were able to achieve early weight loss, sustained reduction was not obtained. The reasons are not all known, but are believed to be related to several factors. One of which is that the stomach stretches over time increasing volume while psychological drivers motivate patients to find creative approaches to literally eat around the smaller pouch.
There are two surgical procedures that successfully produce long-term weight loss; the Roux-en-Y gastric bypass and the biliopancreatic diversion with a duodenal switch (BPD). Both procedures reduce the size of the stomach plus shorten the effective-length of intestine available for nutrient absorption. Reduction of the stomach size reduces stomach capacity and the ability of the patient to take in food. Bypassing the Duodenum makes it more difficult to digest fats, high sugar and carbohydrate-rich foods. One objective of the surgery is to provide feedback to the patient by producing a dumping syndrome if they do eat these food products. Dumping occurs when carbohydrates directly enter the jejunum without being first conditioned in the Duodenum. The result is that a large quantity of fluid is discharged into the food from the intestinal lining. The total effect makes the patient feel light-headed and results in severe diarrhea. For reasons that have not been determined the procedure also has an immediate therapeutic effect on diabetes.
Although the physiology seems simple, the exact mechanism of action in these procedures is not understood. Negative feedback is provided from both regurgitation into the esophagus and dumping when large volumes of the wrong foods are eaten. Eventually, patients learn that in order to avoid both these issues they must be compliant with the dietary restrictions imposed by their modified anatomy. In the BPD procedure, large lengths ofjejunum are bypassed resulting in malabsorption and therefore, reduced caloric uptake. In fact, the stomach is not reduced in size as much in the BPD procedure so that the patient is able to consume sufficient quantities of food to compensate for the reduced absorption. This procedure is reserved for the most morbidly obese as there are several serious side effects of prolonged malabsorption.
Laparoscopic techniques have been applied to these surgeries in an attempt to improve the patient outcomes. While the laparoscopic techniques provide fewer surgical complications, they continue to expose these very ill patients to high operative risk in addition to requiring an enormous level of skill by the surgeon.
While surgery seems to be an effective answer, the current invasive procedures may often times not be acceptable with the aforementioned and additional potential complications of anastomotic stricture, gallstone formation, gastroesophageal reflux, bowel obstruction, nutritional deficiencies requiring dietary modification and supplementation for life, incisional hernias, diarrhea, abdominal bloating, and malodorous flatus/stool.
Additionally, the devices that have been proposed as alternatives to surgical approaches in the literature, as well as the surgical approaches, provide a general approach of malabsorption of all nutritional components of the ingested foods. Further, the most favorable surgical procedure functions by the elimination of contact of ingested food with the absorptive tissues of the Duodenum. The mechanism of the bypass, while not being fully understood, appears to limit the absorption of the carbohydrate and simple sugar components of the ingested food, as evidenced by the generally immediate reduction in the blood sugar levels of treated patients. Additionally, devices or newer surgical approaches that demonstrate this reduction of blood sugars are deemed successful, despite the potential creation of generalized malnutrition.
In the article “Dietary Influences on Gastric Emptying of Carbohydrate versus Fat in the Rat”, by Trout et. al., published in the Journal of Nutrition; 107: 104-111, 1977, it was determined that “gravity tends to hold back the fat from leaving the stomach, allowing glucose in aqueous solution to be preferentially emptied” and further that “a sizable portion of the starch in starch-containing meals became suspended in water during and shortly after being ingested, and the starch suspension was then emptied from the stomach preferentially to fat-containing particulate matter”. It would appear that this functionality of the natural separation of the glucose, or solubilized sugars, as well as the suspended starches and the subsequent acceleration of these components through the pyloric valve into the Duodenum could be eliminated and thereby prevent the blood sugar from elevating while not inhibiting the absorption of the necessary dietary nutrients that are critical to cellular survival.
There remains a need for a less invasive and reversible method of altering patients eating behavior while reducing the dietary impact of foods that are incompatible with diabetic metabolic disorders. There have been attempts in this art to provide medical devices and procedures to address this need.
In U.S. Pat. No. 4,398,910, Blake, et. al. discloses a device for providing drainage from a surgical wound during the post-surgical period of healing.
In U.S. Pat. Nos. 4,501,264; 4,641,653 and 4,763,653; Rockey, discloses medical sleeve devices for placement in a patient's stomach. The medical sleeve described in these patents is intended to reduce the surface area available for absorption in the stomach without affecting the volume of the stomach nor will the described device isolate ingested food from stomach secretions. The medical sleeve is not configured to be deployed in a patient's small intestine and will not have an appreciable impact on the digestion of the ingested food.
In U.S. Pat. No. 4,134,405, Smit, U.S. Pat. No. 4,315,509 Smit, U.S. Pat. No. 5,306,300 Berry, and U.S. Pat. No. 5,820,584 Crabb, sleeve devices are described and are intended to be placed at the lower end of the stomach and therefore do not serve to isolate ingested food from the digestive secretions of the stomach. These sleeve devices are not configured to be deployed in a patient's stomach or to effectively reduce the volume of the patient's stomach or small intestine.
In U.S. Patent Application US 2003/0040804, Stack et al. describe a satiation device to aid in weight loss by controlling feelings of hunger. The patent application describes an antral tube that expands into the Antrum of the stomach to create a feeling of satiation. The devices described are not configured to isolate ingested food and liquids from digestive secretions in the stomach or the intestines.
In U.S. Patent Application US 2003/0040808, Stack et al. describe a satiation device for inducing weight loss in a patient that includes a tubular prosthesis positionable at the gastroesophageal junction region, preferably below the z-line. The prosthesis is placed such that an opening at its proximal end receives masticated food from the esophagus, and such that the masticated food passes through the pouch and into the stomach via an opening in its distal end. The pouch serves to delay the emptying of food into the stomach, thereby providing the patient a sense of fullness prior to filling the stomach.
In U.S. Patent Application US 2003/0093117, Sadaat describes an implantable artificial partition that includes a plurality of anchors adapted for intraluminal penetration into a wall of the gastro-intestinal lumen to prevent migration or dislodgement of the apparatus, and a partition, which may include a drawstring or a toroidal balloon, coupled to the plurality of anchors to provide a local reduction in the cross-sectional area of the gastro-intestinal lumen. The reduction in the cross-sectional area of the lumen delays motility of ingested food, thereby increasing the sense of satiety that the patient experiences.
In U.S. Patent Application US 2003/0120265, Deem et al. describe various obesity treatment tools and methods for reducing the size of the stomach pouch to limit the caloric intake as well as to provide an earlier feeling of satiety. The smaller pouches may be made using individual anchoring devices, rotating probes, or volume reduction devices applied directly from the interior of the stomach. A pyloroplasty procedure to render the pyloric sphincter incompetent and a gastric bypass procedure using atraumatic magnetic anastomosis devices are also described.
In U.S. Patent Application US 2003/0144708, Starkebaum describes methods and systems for treating patients suffering from eating disorders and obesity using electrical stimulation directly or indirectly to the Pylorus of a patient to substantially close the Pylorus lumen to inhibit emptying of the stomach.
In U.S. Patent Number 2014/0275747, Connor discloses a device that is comprised of two passages for food to travel through a patient's digestive tract, referred to as an Adjustable Gastrointestinal Bifurcation. The device has two openings that are regulated by a flow control member that may at least partially direct ingested food into either opening. The bifurcated device is comprised of two openings that are located at the superior end of the device just below the esophageal sphincter. The flow control member is capable of adjustment from a remote location and may direct food into either a passage that enables little absorption of nutrients or a second passage that limits the absorption of nutrients. While the device can divert various food types, it requires a conscious effort on behalf of the user or physician to set the diversion pathway into the correct location for the specific food type that has been ingested. An alternative form of the device requires the implantation or use of a remote sensor within the upper GI tract to sense the type of food being ingested to direct the flow control member. This would require the presence of an invasive foreign object within the upper GI tract, particularly the oral cavity, which would be intolerable to the patient.
In U.S. Pat. No. 7,794,447, Dann, et. al. describe a bypass-type tubular device that may be produced with valves and restrictors to control the exposure of ingested food from digestive secretions. The devices as disclosed form a passage between the upper portion of the stomach, or lower portion of the esophagus, through which ingested food particles will pass. The passage may be produced with valves, or increased porosity, that enables digestive secretions to enter the passage to digest the food contained therein and enables reverse passage of partially digested nutrients to flow back into contact with the absorptive tissues of the GI tract. The restrictive passage may extend as far as the ileum to allow the discharge of partially digested material into portions of the GI tract that may respond and cause the body to eliminate the undigested food from the GI tract. The device, as disclosed, does not differentiate between healthy and unhealthy ingested materials and primarily functions to limit the digestive processes. In the most restrictive form of the device, difficult to digest materials, such as complex proteins, would pass undigested into the ileum and therefore be eliminated from the body without imparting any benefit to the patient.
In U.S. Pat. No. 8,845,674, Brister et. al. describe an inflatable intragastric device that is intended to stimulate a sense of satiety through the introduction of a volume occupying balloon-type device. The device may be orally administered, with an inflation catheter attached in some forms, while self-inflating in other forms, and is preferentially filled with gas to enable the volume occupying device to remain buoyant within the gastric contents. The device is delivered, initially filled, and is subsequently retrieved through an endoscopic procedure once a sufficient weight loss has been demonstrated or period of time has elapsed. Based upon the efficacy of the initial placement, multiple balloons may be installed in an effort to occupy greater space within the stomach. The device provides pressure within the stomach as excess food is ingested, however, the device does not provide differentiation between healthy and unhealthy food selections which enables the subject to defeat the efficacy of the device by preferentially selecting unhealthy calorie dense food options to occupy the remaining space within the stomach.
In U.S. Pat. No. 8,814,898, Gaur, et. al. describe an ingestible, inflatable volume occupying device, a balloon, with a filling catheter attached that is self-deflating. Similar to the balloons disclosed in the Brister patents, the device is delivered in a pill format with the uninflated balloon compacted within the pill capsule. In the compacted form, there is a fine catheter attached that is sized to extend from the patient's mouth upon ingestion. A sterile fluid is delivered through the catheter extending from the oral cavity to inflate the volume occupying device. Unlike the Brister device, the balloon is produced with a feature that provides for self-deflation. The device is produced with an invaginated section that is held secure by a degradable element that is isolated from the abdominal contents, however, it is immersed in the filler fluid. The exposure of the securement element to the filler fluid causes a slow degradation of the element until the strength of the element can no longer maintain the closure of the balloon and releases. The filler fluid is then released from the balloon and the entire structure collapses for passage through the pylorus. While the balloon provides a means to overcome the need to retrieve the balloon after the necessary treatment is complete, as with the Brister device, it only provides the patient with a volume occupying device the provides no selectivity to healthy eating versus high calorie easily absorbed unhealthy options.
Accordingly, there remains an unmet and pressing need to provide a device that is capable of re-directing the most damaging components of food which is ingested, that is reversible, that does not inhibit the digestion of the healthy components of ingested food, that does not rely on patient inputs to function properly, and that provides negative biological feedback to inhibit the ingestion of simple sugars and carbohydrates.